Infusion apparatus with constant force spring energy source

ABSTRACT

A fluid dispenser for use in controllably dispensing fluid medicaments, such as antibiotics, oncolytics, hormones, steroids, blood clotting agents, analgesics, bio-pharmaceuticals and like medicinal agents from a reservoir that has been filled from pre-filled containers. The fluid dispenser includes a housing to which fill-vials can be connected for filling the dispenser reservoir with the fluid, and a stored energy source provided in the form of a substantially constant-force spring that provides the force necessary to continuously and uniformly expel fluid from the device reservoir. The fluid dispenser also includes a fluid flow control assembly that precisely controls the flow of the medicament solution to the patient.

This is a Divisional application of U.S. Ser. No. 10/634,625 filed Aug.4, 2003 now U.S. Pat. No. 7,220,244.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medicament infusion devices.More particularly, the invention concerns an improved apparatus forinfusing medicinal agents into an ambulatory patient at specific ratesover extended periods of time, which apparatus includes a novel constantforce spring energy source, and a novel flow rate control means forprecisely controlling the rate of fluid flow from the reservoir of thedevice.

2. Discussion of the Prior Art

A number of different types of medicament dispensers for dispensingmedicaments to ambulatory patients have been suggested. Many of thedevices seek either to improve or to replace the traditional gravityflow and hypodermic syringe methods, which have been the standard fordelivery of liquid medicaments for many years.

The prior art gravity flow methods typically involve the use ofintravenous administration sets and the familiar flexible solution bagsuspended above the patient. Such gravametric methods are cumbersome,imprecise and require bed confinement of the patient. Periodicmonitoring of the apparatus by the nurse or doctor is required to detectmalfunctions of the infusion apparatus.

Many medicinal agents require an intravenous route for administrationthus bypassing the digestive system and precluding degradation by thecatalytic enzymes in the digestive tract and the liver. The use of morepotent medications at elevated concentrations has also increased theneed for accuracy in controlling the delivery of such drugs. Thedelivery device, while not an active pharmacologic agent, may enhancethe activity of the drug by mediating its therapeutic effectiveness.Certain classes of new pharmacologic agents possess a very narrow rangeof therapeutic effectiveness, for instance, too small a dose results inno effect, while too great a dose can result in a toxic reaction.

For those patients that require frequent injections of the same ordifferent amounts of medicament, the use of the hypodermic syringemethod of delivery is common. However for each injection, it isnecessary to first draw the injection dose into the syringe, then checkthe dose and, after making certain that all air has been expelled fromthe syringe, finally, inject the dose either under bolus or slow pushprotocol. This cumbersome and tedious procedure creates an unacceptableprobability of debilitating complications, particularly for the elderlyand the infirm.

As will be appreciated from the discussion, which follows, the apparatusof the present invention is uniquely suited to provide precise fluiddelivery management at a low cost in those cases where a variety ofprecise dosage schemes with infusion over time are of utmost importance.An important aspect of the apparatus of the present invention is theprovision of novel fill means for filling the reservoir of the deviceusing conventional medicament vials or cartridge containers of varioustypes having a pierceable septum. Another unique feature of theapparatus of the present invention is the provision of various fluidflow rate control means, including an embedded micro-fluidic capillaryflow rate control means which enables precise control of the rate offluid flow of the medicament to the patient. More particularly, theapparatus of the present invention includes a unique, adjustable fluidflow rate mechanism, which enables the fluid contained within thereservoir of the device to be precisely dispensed at various selectedrates over extended periods of time.

The apparatus of the present invention can be used with minimalprofessional assistance in an alternate health care environment, such asthe home. By way of example, devices of the invention can be comfortablyand conveniently removably affixed to the patient's body or clothing andcan be used for the continuous infusion of injectable anti-infectives,hormones, steroids, blood clotting agents, analgesics, and likemedicinal agents. Similarly, the devices of the invention can be usedfor most IV chemotherapy and can accurately deliver fluids to thepatient in precisely the correct quantities and at extended micro-fusionrates over time.

By way of summary, the apparatus of the present invention uniquelyovercomes the drawbacks of the prior art by providing a novel,disposable dispenser of simple but highly reliable construction. Aparticularly important aspect of the apparatus of the present inventionresides in the provision of a novel, self-contained energy source in theform of a substantially constant-force spring that provides the forcenecessary to uniformly and precisely dispense, from the devicereservoir, that is filled with various solutions from standardpre-filled vial containers that can be conveniently loaded into theapparatus. Because of the simplicity of construction of the apparatus ofthe invention, and the straightforward nature of the energy source, theapparatus can be manufactured at low cost without in any way sacrificingaccuracy and reliability.

With regard to the prior art, one of the most versatile and unique fluiddelivery apparatus developed in recent years is that developed by thepresent inventor and described in U.S. Pat. No. 5,205,820. Thecomponents of this novel fluid delivery apparatus generally include: abase assembly, an elastomeric membrane serving as a stored energy means,fluid flow channels for filling and delivery, flow control means, acover, and an ullage which comprises a part of the base assembly.

Another prior art patent issued to the present applicant, namely U.S.Pat. No. 5,743,879, discloses an injectable medicament dispenser for usein controllably dispensing fluid medicaments such as insulin,anti-infectives, analgesics, oncolylotics, cardiac drugsbio-pharmaceuticals, and the like from a pre-filled container at auniform rate. The dispenser, which is quite dissimilar in constructionand operation from that of the present invention, includes a storedenergy source in the form of a compressively deformable, polymericelastomeric member that provides the force necessary to controllablydischarge the medicament from a prefilled container, which is housedwithin the body of the device. After having been deformed, thepolymeric, elastomeric member will return to its starting configurationin a highly predictable manner.

Another important prior art fluid delivery device is described in theU.S. Pat. No. 6,063,059 also issued to the present inventor. Thisdevice, while being of a completely different construction, embodies acompressible-expandable stored energy source somewhat similar to thatused in the apparatus of the present invention.

Still another prior art fluid delivery device, in which the presentinventor is also named as an inventor, is described in U.S. Pat. No.6,086,561. This latter patent incorporates a fill system that makes useof conventional vials and cartridge medicament containers.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a compact fluiddispenser for use in controllably dispensing fluid medicaments, such as,antibiotics, oncolytics, hormones, steroids, blood clotting agents,analgesics, bio-pharmaceuticals and like medicinal agents from areservoir that has been filled from pre-filled containers.

Another object of the invention is to provide a small, compact fluiddispenser that includes a housing to which fill-vials can be connectedfor filling the dispenser reservoir with the fluid.

Another object of the invention is to provide a dispenser in which astored energy source is provided in the form of a substantiallyconstant-force spring that provides the force necessary to continuouslyand uniformly expel fluid from the device reservoir.

Another object of the invention is to provide a dispenser of the classdescribed which includes a fluid flow control assembly that preciselycontrols the flow of the medicament solution to the patient.

Another object of the invention is to provide a dispenser that includesprecise variable flow rate selection.

Another object of the invention is to provide a dispenser that includesa disabling mechanism for disabling the device and rendering it inertfollowing use.

Another object of the invention is to provide a fluid dispenser which isadapted to be used at point of care being there filled with conventionalpre-filled drug containers to deliver beneficial agents therefrom in aprecise and sterile manner.

Another object of the invention is to provide a fluid dispenser of theclass described which is compact, lightweight, is easy for ambulatorypatients to use, is fully disposable, and is extremely accurate so as toenable the infusion of precise doses of medicament over prescribedperiods of time.

Another object of the invention is to provide a device of the characterdescribed which embodies a novel fluid volume indicator that provides areadily discernible visual indication of the volume of fluid remainingin the device reservoir.

Another object of the invention is to provide a self-containedmedicament dispenser which is of very simple construction and yetextremely reliable in use.

Another object of the invention is to provide a fluid dispenser asdescribed in the preceding paragraphs which is easy and inexpensive tomanufacture in large quantities.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a generally perspective view of one embodiment of themedicament infusion apparatus of the present invention for dispensingfluids at a uniform rate.

FIG. 2 is a top plan view of the embodiment of the medicament infusionapparatus shown in FIG. 1.

FIG. 3 is a bottom plan view of the apparatus shown in FIG. 1.

FIG. 4 is a cross-sectional view taken along lines 4-4 of FIG. 3.

FIG. 4A is a greatly enlarged, fragmentary, cross-sectional view of aportion of the bellows component of the apparatus shown in FIG. 4.

FIG. 4B is an enlarged, cross-sectional view of the area designated as4B in FIG. 4.

FIGS. 4B-1 is an enlarged, cross-sectional view of the elastomeric bandshown in FIG. 4B.

FIG. 4C is an enlarged, cross-sectional view of the area designated as4C in FIG. 4.

FIG. 4C-1 is an enlarged, cross-sectional view of the elastomeric bandshown in FIG. 4C.

FIG. 5 is an enlarged, generally perspective view of one form of theconstant force spring of the apparatus shown in FIG. 4.

FIG. 6 is an enlarged, cross-sectional view of the area designated as“6” in FIG. 5.

FIG. 7 is an enlarged, generally perspective view of an alternate formof the constant force spring of the apparatus of the invention.

FIG. 8 is a cross-sectional view similar to FIG. 4, but showing thefluid reservoir filled with fluid.

FIG. 8A is an enlarged, cross-sectional view of the fill-vial of theapparatus of the invention shown in FIG. 4.

FIG. 9 is a left end view of the apparatus shown in FIG. 1.

FIG. 10 is a cross-sectional view taken along lines 10-10 of FIG. 4.

FIG. 10A is a cross-sectional view taken along lines 10A-10A of FIG. 10.

FIG. 11 is a right end view of the apparatus shown in FIG. 1.

FIG. 12 is a cross-sectional view taken along lines 12-12 of FIG. 4.

FIG. 13 is a cross-sectional view taken along lines 13-13 of FIG. 4.

FIG. 14 comprises a generally perspective, exploded view of the interiorcomponents of the assembly shown in FIG. 4.

FIGS. 14A and 14B when considered together comprise a generallyperspective, exploded view of the snap together casing of the deviceshown in FIG. 14.

FIG. 14C is an end view of the snap together casing component FIG. 14A.

FIG. 14D is a view taken along lines 14D-14D of FIG. 14C.

FIG. 15 is a generally perspective, front view of one form of the fluidflow control assembly of the apparatus of the invention.

FIG. 16 is a generally perspective, exploded front view of the fluidflow control assembly shown in FIG. 15.

FIG. 17 is a greatly enlarged, fragmentary cross-sectional view of oneof the flow control channels formed in the flow control member shown inthe central portion of FIG. 16.

FIG. 18 is a generally perspective, rear view of the fluid flow controlassembly of the apparatus of the invention.

FIG. 19 is a generally perspective, exploded rear view of the fluid flowcontrol assembly shown in FIG. 18.

FIG. 20 is a generally perspective view of an alternate form of the flowcontrol member of the invention.

FIG. 21 is a generally perspective view of still another form of theflow control member of the invention.

FIG. 22 is a front view of the assembly shown in FIG. 15.

FIG. 23 is a cross-sectional view taken along lines 23-23 of FIG. 22.

FIG. 24 is a cross-sectional view taken along lines 24-24 of FIG. 23.

FIG. 25 is a cross-sectional view taken along lines 25-25 of FIG. 23.

FIG. 26 is a view taken along lines 26-26 of FIG. 23.

FIG. 27 is a generally perspective view of an alternate embodiment ofthe medicament infusion apparatus of the present invention fordispensing fluids at a uniform rate.

FIG. 28 is a top plan view of the embodiment of the medicament infusionapparatus shown in FIG. 27.

FIG. 29 is a bottom plan view of the apparatus shown in FIG. 27.

FIG. 30 is a cross-sectional view taken along lines 30-30 of FIG. 29.

FIG. 30A is an enlarged, cross-sectional view of the area designated as30A in FIG. 30.

FIG. 30B is an enlarged, cross-sectional view of the elastomeric sealshown in FIG. 30.

FIG. 31 is a cross-sectional view similar to FIG. 30, but showing thefluid reservoir filled with fluid.

FIG. 32 is a left end view of the apparatus shown in FIG. 27.

FIG. 33 is a cross-sectional view taken along lines 33-33 of FIG. 30.

FIG. 34 is a right end view of the apparatus shown in FIG. 27.

FIG. 35 is a cross-sectional view taken along lines 35-35 of FIG. 30.

FIG. 36 is a cross-sectional view taken along lines 36-36 of FIG. 30.

FIGS. 37 and 37A when considered together comprise a generallyperspective, exploded view of the assembly shown in FIG. 30 (hereinaftercollectively referred to as FIG. 37).

FIG. 37B is an end view of the snap together housing component shown inthe lower left hand portion of FIG. 37A.

FIG. 37C is a view taken along lines 37C-37C of FIG. 37B.

FIG. 38 is a generally perspective view of yet another embodiment of themedicament infusion apparatus of the present invention for dispensingfluids at a uniform rate.

FIG. 39 is a top plan view of the embodiment of the medicament infusionapparatus shown in FIG. 38.

FIG. 40 is a bottom plan view of the apparatus shown in FIG. 38.

FIG. 41 is a cross-sectional view taken along lines 41-41 of FIG. 40.

FIG. 41A is an enlarged, cross-sectional view of the fill-vial cartridgeof the apparatus of the invention shown in FIG. 41

FIG. 41B is an enlarged, cross-sectional view of the area designated as41B in FIG. 41.

FIG. 41C is an enlarged, cross-sectional view of the area designated as41C in FIG. 41.

FIG. 41D is an enlarged, cross-sectional view of the elastomeric sealingband shown in the area of FIG. 41C that is designated as 41D.

FIG. 42 is a cross-sectional view similar to FIG. 41, but showing thefluid reservoir filled with fluid.

FIG. 43 is a left end view of the apparatus shown in FIG. 38.

FIG. 44 is a cross-sectional view taken along lines 44-44 of FIG. 41.

FIG. 45 is a right end view of the apparatus shown in FIG. 38.

FIG. 46 is a cross-sectional view taken along lines 46-46 of FIG. 41.

FIG. 47 is a cross-sectional view taken along lines 47-47 of FIG. 41.

FIG. 48 comprises a generally perspective, exploded view of the interiorcomponents of the assembly shown in FIG. 41 ( ).

FIG. 48A is a generally perspective, exploded view of the snap togetherhousing components of the device shown in FIG. 41.

FIG. 48B is an end view of the snap together housing component shown inthe lower left hand portion of FIG. 48A.

FIG. 48C is a view taken along lines 48C-48C of FIG. 48B.

FIG. 48D is a generally perspective view of the casing of the devicethat houses the pusher member that acts upon the fill vial component ofthe device.

FIG. 49 is a generally perspective view of still another embodiment ofthe medicament infusion apparatus of the present invention fordispensing fluids at a uniform rate.

FIG. 50 is a top plan view of the embodiment of the medicament infusionapparatus shown in FIG. 49.

FIG. 51 is a bottom plan view of the apparatus shown in FIG. 49.

FIG. 52 is a cross-sectional view taken along lines 52-52 of FIG. 51.

FIG. 52A is an enlarged, cross-sectional view of the area designated as52A in FIG. 52.

FIG. 52B is an enlarged, cross-sectional view of the area designated as52B in FIG. 52.

FIG. 52C is an enlarged, cross-sectional view of the elastomeric sealingband shown in FIG. 52B.

FIG. 53 is an enlarged cross-sectional view of the lowermost cartridgereconstitution vial of the apparatus of the invention shown in FIG. 52.

FIG. 54 is a cross-sectional view taken along lines 54-54 of FIG. 53.

FIG. 55 is an enlarged cross-sectional view of an alternate form of thelowermost cartridge fill by pass vial of the apparatus of the inventionshown in FIG. 52.

FIG. 56 is a cross-sectional view taken along lines 56-56 of FIG. 55.

FIG. 57 is a cross-sectional view similar to FIG. 52, but showing thefluid reservoir filled with fluid.

FIG. 58 is a left end view of the apparatus shown in FIG. 49.

FIG. 59 is a cross-sectional view taken along lines 59-59 of FIG. 52.

FIG. 60 is a right end view of the apparatus shown in FIG. 49.

FIG. 61 is a cross-sectional view taken along lines 61-61 of FIG. 52.

FIG. 62 is a cross-sectional view taken along lines 62-62 of FIG. 52.

FIGS. 63 and 63A when considered together comprise a generallyperspective, exploded view of the assembly shown in FIG. 52 (hereinaftercollectively referred to as FIG. 63).

FIG. 63B is an end view of the snap together housing component shown inthe lower left hand portion of FIG. 63A.

FIG. 63B is a view taken along lines 63B-63B of FIG. 63B.

FIG. 64 is a generally perspective view of still another embodiment ofthe medicament infusion apparatus of the present invention fordispensing fluids at a uniform rate.

FIG. 65 is a top plan view of the embodiment of the medicament infusionapparatus shown in FIG. 64.

FIG. 66 is a bottom plan view of the apparatus shown in FIG. 64.

FIG. 67 is a longitudinal, cross-sectional view of the apparatus shownin FIG. 64.

FIG. 67A is an enlarged, cross-sectional view of the area designated as67A in FIG. 67.

FIG. 68 is a cross-sectional view taken along lines 68-68 of FIG. 67.

FIG. 69 is a cross-sectional view similar to FIG. 67, but showing thefluid reservoir filled with fluid.

FIG. 70 is a cross-sectional view taken along lines 70-70 of FIG. 67.

FIG. 71 is a left end view of the apparatus shown in FIG. 64.

FIG. 72 is a right end view of the apparatus shown in FIG. 64.

FIG. 73 is a cross-sectional view taken along lines 73-73 of FIG. 67.

FIG. 74 is a cross-sectional view taken along lines 74-74 of FIG. 67.

FIGS. 75 and 75C when considered together comprise a generallyperspective, exploded view of the assembly shown in FIG. 67 (hereinaftercollectively referred to as FIG. 75).

FIG. 75A is a view taken along lines 75A-75A of FIG. 75C.

FIG. 75B is a view taken along lines 75-75B of FIG. 75A.

FIG. 76 is a generally perspective, exploded view of the flow ratecontrol means of this latest form of the apparatus of the presentinvention.

FIG. 77 is a generally perspective, front exploded view of the flow ratecontrol means shown in FIG. 76.

FIG. 78 is a front view of the forward most rate control plate of theflow control means shown in FIG. 78.

FIG. 79 is a cross-sectional view taken along lines 79-79 of FIG. 78.

FIG. 80 and FIG. 80A, when considered together comprise an exploded,generally perspective view of the rate control plates of the ratecontrol assembly of the invention.

FIG. 81, when considered in its entirety, comprises a front view of eachof the rate control plates of the assembly shown in FIGS. 80 and 80A.

FIG. 82 is a view taken along lines 82-82 of FIG. 80.

FIG. 82A is a rear view of the inlet manifold component.

FIG. 82B is a cross-sectional view taken along lines 82B-82B of FIG.82A.

FIG. 83 is a view taken along lines 83-83 of FIG. 80.

FIG. 83A is a side-elevational view of the rate control assembly shownin FIG. 77 as it appears in a sealably interconnected configuration.

FIG. 83B is a front perspective view of the outlet manifold component.

FIG. 83C is a rear perspective view of the outlet manifold component.

FIG. 84 is a front view of the assembly shown in FIG. 83.

FIG. 84A is a cross-sectional view taken along lines 84A-84A of FIG. 84.

FIG. 85 is a rear view of the outlet manifold component of the assemblyshown in FIG. 83.

FIG. 85A is a cross-sectional view taken along lines 85A-85A of FIG. 85.

FIG. 86 is a generally perspective, partially exploded view of thecontrol assembly.

FIG. 86A is a front view of the outlet manifold portion of the assemblyshown in FIG. 86.

FIG. 87 is a rear view of the first from the left, rate control plate ofthe assembly shown in FIG. 80.

FIG. 88 is a front view of the rate control plate shown in FIG. 87.

FIG. 89 is a cross-sectional view taken along lines 89-89 of FIG. 88.

FIG. 90 is a rear view of the second from the left, rate control plateshown in FIG. 80.

FIG. 91 is a front view of the rate control plate shown in FIG. 90.

FIG. 92 is a cross-sectional view taken along lines 92-92 of FIG. 91.

FIG. 93 is a fragmentary, cross-sectional view of the forward portion ofthe outlet manifold of the flow control means shown sealably mated withthe rate control knob of the apparatus of the invention.

FIG. 93A is an enlarged, fragmentary, cross-sectional view of the upperportion of FIG. 93.

FIG. 93B is an enlarged, fragmentary, cross-sectional view of the lowerportion of FIG. 93.

FIG. 93C is an enlarged, cross-sectional view of one of the elastomericsealing bands shown in FIG. 93A.

FIG. 93D is an enlarged, cross-sectional view of the other elastomericsealing bands shown in FIG. 93A.

FIG. 94 is a cross-sectional view taken along lines 94-94 of FIG. 93.

FIG. 95 is a cross-sectional view similar to FIG. 94, but showing therate control knob rotated to second rate control position.

FIG. 96 is a generally perspective view of yet another embodiment of themedicament infusion apparatus of the present invention for dispensingfluids at a uniform rate.

FIG. 97 is a top plan view of the embodiment of the medicament infusionapparatus shown in FIG. 96.

FIG. 98 is a bottom plan view of the apparatus shown in FIG. 97.

FIG. 99 is a longitudinal, cross-sectional view of the apparatus shownin FIG. 96.

FIG. 99A is an enlarged, cross-sectional view of the area designated as99A in FIG. 99.

FIG. 99B is an enlarged, cross-sectional view of the area designated as99B in FIG. 99.

FIG. 100 is a cross-sectional view taken along lines 100-100 of FIG. 99.

FIG. 100A is a generally perspective front view of the flow controlassembly of the form of the invention shown in FIG. 100.

FIG. 100B is a generally perspective rear view of the flow controlassembly.

FIG. 100C is a longitudinal, cross-sectional view of the flow controlassembly.

FIG. 100D is a generally perspective, exploded view of the flow controlassembly.

FIG. 101 is a cross-sectional view similar to FIG. 99, but showing thefluid reservoir filled with fluid.

FIG. 102 is a cross-sectional view taken along lines 102-102 of FIG. 99.

FIG. 103 is a left-end view of the apparatus shown in FIG. 96.

FIG. 104 is a right-end view of the apparatus shown in FIG. 96.

FIG. 105 is a cross-sectional view taken along lines 105-105 of FIG. 99.

FIGS. 106 and 106B, when considered together, comprise a generallyperspective, exploded view of the assembly shown in FIG. 99 (hereinaftercollectively referred to as FIG. 106).

FIG. 106C is an end view of one of the snap together housing componentsshown in the lower left hand portion of FIG. 100B.

FIG. 106A is a view taken along lines 106A of FIG. 106.

FIG. 107 is a generally perspective view of still another embodiment ofthe medicament infusion apparatus of the present invention fordispensing fluids at a uniform rate.

FIG. 107A is a generally perspective, exploded view of the embodiment ofthe apparatus shown in FIG. 107.

FIG. 108 is a longitudinal, cross-sectional view of the apparatus shownin FIG. 107.

FIG. 108A is an enlarged, cross-sectional view of the area designated as108A of FIG. 108.

FIG. 108B is an enlarged, cross-sectional view of the area designated as108B in FIG. 108.

FIG. 108C is an enlarged, cross-sectional view of the area designated as108C in FIG. 108.

FIG. 109 is a left-end view of the apparatus shown in FIG. 107.

FIG. 110 is a cross-sectional view taken along lines 110-110 of FIG.108.

FIG. 110A is a view taken along lines 110A-110A of FIG. 110.

FIG. 111 is a side elevational view of the vial cover portion of theapparatus shown in FIG. 108.

FIG. 112 is a view taken along lines 112-112 of FIG. 111.

FIG. 113 is an enlarged, cross-sectional view of the upper fill-vial ofthe apparatus of the invention shown in FIG. 108.

FIG. 114 is a view taken along lines 114-114 of FIG. 113.

FIG. 115 is an enlarged, cross-sectional view of the lowermost cartridgefill-vial of the apparatus of the invention shown in FIG. 108.

FIG. 116 is a view taken along lines 116-116 of FIG. 115.

FIG. 117 is an enlarged, cross-sectional view of an alternate form ofthe lowermost cartridge fill-vial of the apparatus of the inventionshown in FIG. 108.

FIG. 118 is a view taken along lines 118-118 of FIG. 117.

DESCRIPTION OF THE INVENTION

Referring to the drawings and particularly to FIGS. 1 through 14, oneembodiment of the dispensing apparatus of the present invention is thereillustrated and generally designated by the numeral 52. The apparatushere comprises a snap and bond moldable plastic outer housing 54 havinga first, second and third portions 54 a, 54 b and 54 c respectively.Disposed within outer housing 54 is a first, expandable housing 56having a fluid reservoir 58 (FIGS. 4 and 8) that is provided with aninlet passageway 60 for permitting fluid flow into the fluid reservoirand an outlet 64 for permitting fluid flow from the fluid reservoir.Expandable housing 56, which can be constructed from a metal or plasticmaterial and can include a surface treatment and coating of thecharacter presently to be described, comprises a bellows structurehaving an expandable and compressible, accordion-like, annular-shapedsidewall 56 a, the configuration of which is best seen in FIGS. 4 and 8.

Disposed within second portion 54 b of outer housing 54 is the novelstored energy means of the invention for acting upon inner expandablehousing 56 in a manner to cause the fluid contained within fluidreservoir 58 to controllably flow outwardly of the housing. In thepresent form of the invention, this important stored energy meanscomprises a constant force extension spring member 67 that is carriedwithin cavities or wells 54 a formed in the second portion 54 b of theouter housing (see FIG. 14).

Spring member 67 is first extended in the manner shown in FIG. 8 byfluid flowing into reservoir 58 and then controllably retracts in themanner shown in FIG. 4 to cause fluid flow from the outer housingthrough the dispensing means of the invention. Stored energy member orconstant-force, double-spool, single-layer spring 67, which is a specialvariety of extension spring, is readily commercially available fromseveral sources, including Barnes Group Inc. of Bristol, Conn.; StockDrive Products/Sterling Instrument of Hyde Park, N.Y. and WalkerCorporation of Ontario, Calif. Constant force extension spring 67 isbasically a high stress, long deflection device that offers greatadvantages when used in applications, such as the present application,where very low or zero gradient is desired, where space is a factor andwhere very high reliability, accuracy, and forced tolerance is required.Constant force springs, such as spring 67, provides markedly superiorconstant force loading when compared to conventional helical extensionor like conventional types of springs. A constant force spring istypically a roll of pre-stressed, strip of metal that exerts a nearlyconstant restraining force to resist uncoiling. The force is constantbecause the change in the radius of the curvature is constant. Spring 67can be of a laminate construction, such as shown in FIGS. 5 and 6, andidentified as 67 a wherein the laminate construction acts on a pushermember 69 of the character shown in FIG. 4. Alternatively spring 67 cancomprise a pair of cooperatively associated, individual extensionsprings 67 a and 67 b of the character shown in FIG. 7 which havefree-end portions 67 c that are receivable within spring receiving slots71 formed in a specially constructed pusher member 73. Springs 67, 67 aand 67 b can be constructed from a wide variety of materials includingstainless steel and are held in position by opposing positioning meansor cross members 67 d which are of the construction shown in FIGS. 10and 10A.

After the springs are extended in the manner shown by the phantom linesin FIG. 4 and by the solid lines in FIG. 8, the springs will inherentlytend to uniformly return toward their starting configuration and in sodoing will exert a substantially constant force (force over extension orextension over time) on the pusher member 69 which is operably coupledwith the expandable housing 56 in the manner shown in FIGS. 4 and 8. Asthe springs return to their starting configuration, the fluid containedwithin the fluid reservoir 58 will be caused to flow outwardly throughoutlet 64 at a substantially constant rate.

Forming an important aspect of the apparatus of the present invention isfill means carried by the third portion 54 c of outer housing 54 forfilling the reservoir 58 with the fluid to be dispensed. As best seen inFIG. 4, third portion 54 c of the outer housing includes a fluidpassageway 78 that is in communication with inlet 60 of fluid reservoir58. Proximate its lower end 78 a, fluid passageway 78 communicates witha cavity 80 formed within the third portion 54 c of the housing.Disposed within cavity 80 is a pierceable septum 84 that comprises apart of one form of the fill means of this latest form of the invention.Septum 84, which is of conventional construction, is held in position bya retainer 84 a and is pierceable by the needle of the syringe whichcontains the medicinal fluid to be dispensed and which can be used in aconventional manner to fill or partially fill reservoir 58 viapassageway 78. Septum 84 can also be used to accomplish residual drugrecovery from reservoir 58.

Third portion 54 c of housing 54 also includes a chamber 85 fortelescopically receiving a medicament containing shell fill-vial 88. Anelongated support 90, which is disposed within chamber 85, includes athreaded end portion 92 and carries a longitudinally extending,elongated hollow needle 94 having a flow passageway that communicateswith fluid passageway 78 via a stub passageway 97. Chamber 85, elongatedsupport 90 and hollow needle 94 together comprise an alternate form offill means of the apparatus of the invention. The method of operation ofthis alternate form of fill means will presently be described.

Referring particularly to FIG. 8A, the medicament containing fill-vial88 includes a body portion 88 a, having a fluid chamber 100 forcontaining the injectable fluid medicament “F”. Chamber 100 is providedwith a first open end 100 a and second closed end 100 b. First open end100 a is sealably closed by closure means here provided in the form ofan externally threaded elastomeric plunger 102, which is telescopicallymovable within the vial from a first location, where the plunger isdisposed proximate first open end 100 a to a second, device-filllocation where the plunger is disposed proximate second closed end 100b.

After removal of the vial chamber cover 103, which forms a part of thethird portion 54 c of the snap and bond together housing 52 (FIGS. 4 and14), vial 88 can be inserted into chamber 85. As the fill-vial is sointroduced and the plunger 102 is threadably interconnected with end 92of support 90 (FIG. 4), the sharp end of the elongated needle 94 willpierce the central wall 102 a of the elastomeric plunger. Continuouspushing movement of the vial into chamber 85 will cause the structuralsupport 90 to move the elastomeric plunger inwardly of the vial chamber100 in a direction toward the second, or closed, end 100 b of the vialchamber. As the plunger is moved inwardly of the vial, the fluid “F”contained within the vial chamber will be expelled therefrom into thehollow elongated needle 94. As best seen in FIG. 4, the fluid will thenflow past a conventional elastomeric umbrella-type check valve 106,which is mounted within a cavity 107 formed in lower portion 54 c of theouter housing. Next, the fluid will flow into stub passageway 97 andthence into passageway 78. Umbrella-type check valve 106 functions in aconventional manner to control fluid flow from the elongated hollowneedle 94 toward fluid passageway 78. From passageway 78, the fluid willflow into inlet passageway 60 and then into reservoir 58 of the bellowscomponent 56.

As the fluid flows from either of the fill means of the invention intothe bellows reservoir 58, the bellows will expand from the collapsedconfiguration shown in FIG. 4 into the expanded configuration shown inFIG. 8. As best seen in FIG. 4A, the inner wall of the bellows isprovided with one or more protective coatings “C” that are compatiblewith the fluids contained within reservoir 58. This coating can beaccomplished by several different processes. One process that isextremely clean, fast and effective is plasma processing. In particularthis technique allows for any of the following: plasma activation,plasma induced grafting and plasma polymerization of molecular entitieson the surface of the bellows. For cases where an inert hydrophobicinterface is desired, plasma-using fluorine-containing molecules may beemployed. In this regard, the bellows surface may be cleaned with aninert gas plasma, and subsequently, a fluorine-containing plasma may beused to graft these molecules to the surface. Alternatively, if ahydrophilic surface is desired (e.g. for drug solutions that are highlycorrosive or in oil-based solvents) an initial plasma cleaning may bedone, followed by a plasma polymerization using hydrophilic monomers.

As the bellows member expands it will urge a telescopically movablevolume indicator member 110, which is carried within a second portion 54b of the housing and which is interconnected with pusher member 69,rearwardly of the apparatus housing in the manner shown in FIG. 8.Pusher member 69 is stabilized by controller struts 69 a which arelocated on the housing of body half shells 54 c. The forces thus exertedon the spring member 67 by the rearwardly moving pusher member 69 willcause the spring member 67 to expand from its retracted configurationshown in FIG. 4 into the expanded configuration shown in FIG. 8. As thereservoir 58 fills with fluid, any gases trapped within the reservoirwill be vented to atmosphere via vent means “V” mounted in portion 54 aof the housing. This vent means here comprises a gas vent 113 (FIG. 8)that can be constructed of a suitable hydrophobic porous material suchas a porous plastic.

Upon opening the fluid delivery path to the fluid delivery means of theinvention, shown here as a conventional administration set 114 (FIG. 1),the stored energy means, or spring 67, will tend to return to itsstarting configuration thereby controllably urging fluid flow outwardlyof reservoir 58 via the flow control means of the invention thecharacter of which will presently be described.

Administration set 114 is sealably connected to the first portion 54 aof housing 54 by a connector 114 a in the manner shown in FIG. 1 of thedrawings. As illustrated in FIGS. 1 and 4, the proximal end 116 a ofadministration line 116 of the administration set is in communicationwith an outlet fluid passageway 118 which is formed in portion 54 a ofthe outer housing. Disposed between the proximal end 116 a and thedistal end 116 b of the administration line are a conventional clamp117, a conventional gas vent and a conventional filter 113. Provided atthe distal end 116 b of the administration line is a luer connector 122and luer cap 122 a of conventional construction (FIG. 1).

A number of beneficial agents can be contained within shell vial 88 andcan be controllably dispensed from the fluid dispenser to the patientincluding, by way of example, medicaments of various types, drugs,pharmaceuticals, hormones, antibodies, biologically active materials,elements, chemical compounds, or any other suitable material useful indiagnostic cure, medication, treatment or preventing of diseases or themaintenance of the good health of the patient.

As the fluid contained within the bellows reservoir 58 is urgedoutwardly thereof by the stored energy means, the fluid will flow underpressure through a filter means, shown here as a filter 124 that iscarried in a cavity provided in a generally cylindrically shaped flowrate control member 126 (FIG. 19). Flow rate control member 126 forms apart of the flow control means, or flow control assembly 129 of theinvention. As will be better understood from the discussion whichfollows, this important flow control means functions to preciselycontrol the rate of fluid flow outwardly from reservoir 58 and towardthe patient via the administration set.

Peripherally bonded filter 124, which functions to filter particulatematter from the fluid flowing outwardly from reservoir 58 is of acharacter well known to those skilled in the art and can be constructedfrom various readily available materials such as polysolfone andpolypropylene wafers having a desired porosity. After flowing throughfilter 124, the fluid will flow via a stub passageway 125 (FIG. 4) intothe fluid flow distribution means of flow rate control member 126, whichfunctions, in a manner presently to be described, to distribute thefluid into the flow control channels strategically formed in member 126.

Referring particularly to FIGS. 15 through 26, it can be seen that flowcontrol assembly 129 comprises an outer casing 130 having a plurality ofcircumferentially spaced-apart fluid outlets 132, a flow rate controlmember 126, which is telescopically receivable within casing 130 and aselector knob 134 that is interconnected with rate control member 126 inthe manner best seen in FIGS. 15, 16, 18, 19 and 23. A compressiblydeformable elastomeric band 131 sealably interconnects casing 130 withthe housing portion 54 a in the manner shown in FIGS. 4B and 4C. Asillustrated in the drawings, flow rate control member 126 is uniquelyprovided with a plurality of elongated flow control channels 128, eachhaving an inlet 128 b and an outlet 128 a. The flow channels 128 may beof different sizes, lengths, depths, widths and configurations as shownby FIGS. 20 and 21, which depict alternate forms of the flow controlmember. These alternate forms of flow control members with alternatemicro-channel configurations, which are identified in the drawings as126 a and 126 b, have uniquely configured flow control channels 128 c.As used herein, the term “micro-channel” is interchangeable with theterm “mini-channel”. As illustrated in FIG. 17, the flow controlchannels may be rectangular in cross-section. Alternatively, the flowcontrol channels can be semicircular in cross-section, U-shaped incross-section, or they may have any other cross-sectional configurationthat may be appropriate to achieve the desired fluid flowcharacteristics. As previously discussed, where appropriate, channels128 can be coated with one or more special coating “C” with appropriatesurface modification in the manner shown in FIG. 17.

When the flow control member is properly positioned and appropriatelyregistered within outer casing 130, the inner surface of the outercasing wall sealably cooperates with the flow control member channels128 to form a plurality of generally spiral-shaped fluid flowpassageways of different overall lengths and flow capacities. When theflow control member is positioned within the outer casing, a notch 138formed in member 126 receives a tongue 140 provided on casing 130 toprecisely align the outlets 128 a of the flow channels 128 with fluidoutlets 132 formed in casing 130.

Selector knob 134, which comprises a part of the selector means of theinvention, is rotatably connected to portion 54 a of the outer housingand, in a manner presently to be described, functions to rotate theassemblage made up of outer casing 130 and flow control member 126(FIGS. 4 and 14). In this way, a selected outlet 132 in casing 130 canbe selectively aligned with flow passageway 118 provided in portion 54 a(FIG. 4).

As previously discussed herein, as the fluid contained within thebellows reservoir 58 is urged outwardly thereof by the stored energymeans, the fluid will flow under pressure through filter 124, into stubpassageway 125 and then into the distribution means of the inventionwhich functions to distribute fluid from the fluid reservoir to each ofthe plurality of spiral passageways 128 via passageway 142. Thisdistribution means here comprises several radially outwardly extendingflow passageways 142 formed in flow control member 126 (FIG. 25). Thefiltered fluid will fill passageways 142 and then will flow into theplurality of spiral passageways 128 formed in member 126 via outlets 128b, which communicate with passageways 142 (see FIG. 25). The fluidcontained within spiral passageways 128 can flow outwardly of the deviceonly when one of the fluid outlets 132 formed in casing 130 is alignedwith reservoir outlet passageway 118 (FIGS. 8, 18 and 20).

Selection of the passageway from which the fluid is to be dispensed isaccomplished by rotation of the selector knob 134 which, as best seen inFIG. 19 includes a reduced-diameter portion 134 a having a slot 134 bformed therein. As illustrated in FIGS. 16 and 19, slot 134 b is adaptedto receive a spline 146 formed anteriorly of member 126. With thisconstruction, rotation of selector knob 134 will impart part rotation tomember 126. As seen in FIG. 19, inwardly extending spline segment 140 isreceived within slot 138 formed in member 126. Accordingly, rotation ofmember 126 will also impart concomitant rotation to casing member 130.

As shown in FIGS. 18 and 19, selector knob 134 is provided with aplurality of circumferentially spaced-apart indexing cavities 147 thatclosely receive an indexing finger 150, which forms a part of theindexing means of the invention, which means comprises a front bezel 152that is connected to the apparatus housing (see FIGS. 4 and 14).Indexing finger 150 is continuously urged into engagement with aselected one of the indexing cavities 147 by a coil spring 154 that alsoforms a part of the indexing means of the invention. Coil spring 154 canbe compressed by an inward force exerted on an indexing shaft 156 andbutton 156 a that is mounted in locking shaft cover 152 and is movablefrom an extended position to an inward, finger release position whereinspring 154 is compressed and finger 150 is retracted from a selectedindexing cavity 147. With finger 150 in its retracted position, it isapparent that control knob 134 can be freely rotated to a positionwherein a gripping member 157 can be aligned with selected flow rateindicia 159 formed on the front bezel 152 of the apparatus housing. Theindicia may be symbols as shown in FIG. 1 or it may be numbers as shownin FIG. 11.

When the selector knob is in the desired position and pressure isreleased on indexing button 156 a, spring 154 will urge finger 150 ofthe indexing means of the invention into locking engagement with one ofthe indexing cavities 147 thereby placing a selected one of thespiral-shaped flow control channels 128 that corresponds with theindicia 159 in communication with the fluid reservoir 58 via passageways125 and 124. As the fluid flows outwardly of the apparatus due to theurging of the stored energy means or spring member 67, the bellowsstructure 56 will be collapsed and at the same time pusher member 69will travel inwardly of the housing. Member 69, which forms a part ofthe volume indicator means of the invention is guided by integralinternal wall structure 69 a of portion 54 c and includes a radiallyoutwardly extending indicating finger 110 that is visible through avolume indicator window 160 that is provided in a second portion 54 b ofthe apparatus housing and also comprises a part of the volume indicatormeans of the invention (FIGS. 1, 2, 10 and 14). Indicia 161, which areprovided on indicator window 160 (FIGS. 2 and 14), function to readilyindicate to the caregiver the amount of fluid remaining within fluidreservoir 58 at any point in time.

Referring to FIGS. 11 and 12, disabling means, shown here as a disablingshaft 164 that is telescopically movable within a passageway 166 formedwithin housing portion 54 a functions to irrevocably disable the deviceand render it inert. More particularly, shaft 164 has a distal end 164a, which, upon insertion of the shaft distal end 164 a into bore 164 c(FIG. 12), will block fluid flow through passageway 118. A friction-fitretainer 164 b normally holds shaft 164 in the retracted position (FIGS.12 and 14). As shown in FIG. 8, a receptacle bore 164 c is provided forreceipt of shaft 164.

Referring now to FIGS. 27 through 37, another embodiment of thedispensing apparatus of the present invention is there illustrated andgenerally designated by the numeral 172. This alternate form of theapparatus of the invention is similar in many respects to that shown inFIGS. 1 through 26 and like numerals are used in FIGS. 27 through 37 toidentify like components. The primary differences between this latestform of the invention and that shown in FIGS. 1 through 26 concern theprovision of a differently configured internal housing and the provisionof a different reservoir fill means for filling the device reservoir.More particularly, as will presently be described in greater detail,this alternate form of fill means comprises two specially designedfill-vials or containers.

As best seen in FIG. 27, the apparatus here comprises an outer housing174 having a first, second and third portions 176, 178 and 180respectively. Disposed within outer housing 174 is an inner, expandablehousing 56 which is identical in construction and operation to thatdescribed in connection with the embodiment of FIGS. 1 through 26.

Disposed within second portion 178 of outer housing 174 is the novelstored energy means of the invention for acting upon inner expandablehousing 56 in a manner to cause the fluid contained within fluidreservoir 58 thereof to controllably flow outwardly of the housing. Inthis latest form of the invention, this stored energy means is alsoidentical in construction and operation to that previously described andcomprises a constant force spring 67.

With regard to the fill means of this latest form of the invention,which is carried by the third portion 180 of the outer housing, thisimportant fill means once again functions to fill the reservoir 58 withthe fluid to be dispensed. This fill means here comprises the previouslydescribed septum-fill and recovery means, which is identical to thatpreviously described, and also includes a vial-fill means which includestwo, rather than the one, shell fill-vials or fill containers.

With respect to the septum-fill means, as illustrated in FIGS. 30 and35, third portion 180 of the outer housing here includes a fluidpassageway 182 which is in communication with inlet 60 of fluidreservoir 58. Proximate its lower end 182 a, fluid passageway 182communicates with a cavity 184 formed within the third portion 180 ofthe housing. Disposed within cavity 184 is a pierceable septum 84 thatcomprises a part of the septum-fill means of this latest form of theinvention. As before, septum 84, which can be a slit septum, is held inposition by a retainer 84 a and is pierceable by the cannula of thesyringe which contains the medicinal fluid to be dispensed and which canbe used in a conventional manner to fill or partially fill reservoir 58via passageway 182.

As best seen in FIG. 30, third portion 180 of the housing also includesa first chamber 186 for telescopically receiving a first medicamentcontaining fill-vial 188 and a second chamber 190 for telescopicallyreceiving a second medicament containing vial 192. Fill-vials 188 and192, which are of identical construction, each cooperates with anelongated support 194 that is disposed within fluid chambers 196 of thevials. Each of the elongated supports has an integrally threaded endportion 194 a and carries a longitudinally extending, elongated hollowneedle 198. Each of the hollow needles 198 has a flow passageway thatcommunicates with fluid passageway 182 via the umbrella check valves andstub passageway 204. First chamber 186, second chamber 190, elongatedsupports 194, and hollow needles 198 together comprise the alternateform of the vial-fill means of the apparatus of the invention. Themethod of operation of this alternate form of fill means will presentlybe described.

Forming another very important aspect of the apparatus of this latestform of the invention is a novel flow control means that is connected tofirst portion 176 of outer housing 174. This flow control means, whichis identical in construction and operation to that described inconnection with the first embodiment of the invention, functions toprecisely control the rate outwardly of fluid flow from reservoir 58(FIG. 31) and toward the patient. As before, the flow control meanscomprises a flow control member 126 that is telescopically receivablewithin casing 130 and a selector knob 134 that is interconnected withcontrol member 126 in the manner shown in FIGS. 15 and 16. When the flowcontrol member is properly positioned within outer casing 130, the innersurface of the outer casing wall cooperates with channels 128 providedin the control member to form a plurality of generally spiral-shapedfluid flow passageways of different overall lengths and flow capacities.Selector knob 134, which is rotatably mounted within housing portion176, functions to rotate the assembly made up of outer casing 130 andflow control member 126 (FIG. 37). In this way, a selected outlet 132 incasing 130 can be selectively aligned with an outlet flow passageway 118provided in forward housing portion 176 (FIG. 30).

Also forming a part of the fluid dispensing apparatus of this latestform of the invention is dispensing means for dispensing fluid to thepatient. This dispensing means is also identical to that previouslydescribed and comprises an administration set 114 that is connected tothe first portion 176 of housing 174 in the manner shown in FIG. 27 ofthe drawings. The proximal end 116 a of administration line 116 of theadministration set is in communication with fluid passageway 118 in themanner best seen in FIGS. 30 and 31.

Turning particularly to FIGS. 30 and 37, each of the shell vials 188 and192 can be seen to be of the same construction as the shell vialillustrated in FIG. 8A and as earlier described herein. After removal ofthe vial cover 201, which forms a part of the third portion of housing174 (FIGS. 30 and 37), vials 188 and 192 can be inserted into chambers186 and 190 respectively. As the fill-vials are so introduced and theplungers 102 thereof are threadably interconnected with ends 194 a ofsupports 194, the sharp ends of the elongated needles 198 will piercethe central walls 102 a of the elastomeric plungers. Continuous pushingmovement of the vials into chambers 186 and 190 will cause thestructural supports 194 to move the elastomeric plungers inwardly of thevial chambers. As the plungers move inwardly of the vial, the fluidcontained within the vial chambers will be expelled therefrom into thehollow elongated needles 198. As best seen in FIG. 30, the fluid willthen flow past umbrella-type check valves 106 and into passageways 204formed in third portion 180 of the apparatus housing. From passageway204 the fluid will flow into passageway 182 and then into reservoir 58of the bellows component 56 via inlet channel 60 (FIGS. 30, 31, and 37).It is to be understood that the vials 188 and 192 can contain the sameor different medicinal fluids and can be introduced into theirrespective chambers either one at a time, or simultaneously.

It is also to be understood that, if desired, the reservoir of thebellows component can be filled by alternate filling means of thecharacter previously described, namely a filling means which comprises asyringe having a needle adapted to pierce the pierceable septum 84 whichis mounted within third portion 180 of the apparatus housing. As thereservoir 58 fills with fluid either from the fill-vials or from thefilling syringe, any gases trapped within the reservoir will be ventedto atmosphere via vent means “V” mounted in portion 176 of the housing.

Upon opening the fluid delivery path to the administration set in aconventional manner, the stored energy means, or member 67, will tend toreturn to its starting configuration thereby controllably urging fluidflow outwardly of reservoir 58 via the flow control means of theinvention which functions in the manner previously described. Indexingmeans of the character previously described functions to index theposition of the selector knob. Similarly disabling means of thecharacter previously described can be used to disable the apparatus ofthis latest form of the invention.

Turning next to FIGS. 38 through 48, still another form of thedispensing apparatus of the present invention is there illustrated andgenerally designated by the numeral 212. This alternate form of theapparatus of the invention is also similar in many respects to thatshown in FIGS. 1 through 26 and like numerals are used in FIGS. 38through 48 to identify like components. The primary difference betweenthis latest form of the invention and that shown in FIGS. 1 through 26is that the vial-fill means for filling the device reservoir is of adifferent configuration from that used in both the first and secondpreviously described embodiments of the invention. More particularly, aswill presently be described in greater detail, this alternate form ofvial-fill means comprises a vial cartridge having a hollow glass orplastic body portion that defines a fluid chamber that is closed by apierceable, elastomeric septum.

As best seen in FIG. 38, the apparatus here comprises an outer housing214 having a first, second and third portions 216, 218 and 220respectively. Disposed within outer housing 214 is an inner, expandablehousing 56 which is identical in construction and operation to thatdescribed in connection with the embodiment of FIGS. 1 through 26.

Disposed within second portion 218 of outer housing 214 is the novelstored energy means of the invention for acting upon inner expandablehousing 56 in a manner to cause the fluid contained within fluidreservoir 58 thereof to controllably flow outwardly of the housing. Inthis latest form of the invention, this stored energy means is alsoidentical in construction and operation to that previously described andcomprises a constant force spring 67.

With regard to the fill means of this latest form of the invention,which is carried by the third portion 220 of the outer housing, asbefore, this important fill means functions to fill the reservoir 58with the fluid to be dispensed. This fill means here comprises thepreviously described septum-fill means, which is identical to thatpreviously described, and also includes the previously mentioned,cartridge-type fill-vial which is of the construction best seen in FIG.41A of the drawings.

As to the septum-fill means, as illustrated in FIG. 41, third portion220 includes a fluid passageway 222 which is in communication with inlet60 of fluid reservoir 58. Proximate its lower end 222 a, fluidpassageway 222 communicates with a cavity formed within the thirdportion 220 of the housing. Disposed within cavity is a pierceableseptum 84 that comprises a part of the septum-fill means of this latestform of the invention. As before, elastomeric septum 84 is held inposition by a retainer 84 a and is pierceable by the needle of thesyringe which contains the medicinal fluid to be dispensed and which canbe used in a conventional manner to fill or partially fill reservoir 58via passageway 222.

Third portion 220 of the housing also includes a first chamber 226 fortelescopically receiving the previously mentioned cartridge fill-vial,which is generally designated in the drawings by the numeral 227. Asshown in FIG. 41A, cartridge fill-vial 227 comprises a hollow glass orplastic body portion 228 that defines a fluid chamber 230. Fill-vial 227has an open first end 232 and a second end 234 that is closed by apierceable, elastomeric septum 236. An elastomeric plunger 237 isreciprocally movable within fluid chamber 230. As shown in FIG. 41, ahollow needle to 240 is mounted within third portion 220 of the devicehousing and is located proximate the inboard end of chamber 226. Hollowneedle 240 is adapted to pierce septum 236 when the fill-vial isinserted into chamber 226 and pushed into the position shown in FIG. 41.More particularly, a pusher member 239 which is housed within a casing239 a (FIG. 48) pushes the fill-vial inwardly of chamber 226.

Forming an important aspect of the apparatus of this latest form of theinvention is a novel flow control means that is connected to firstportion 216 of outer housing 214. This flow control means, which isidentical in construction and operation to that described in connectionwith the first embodiment of the invention, functions to preciselycontrol the rate outwardly of fluid flow from reservoir 58 and towardthe patient. As before, the flow control means comprises a flow controlmember 126 that is telescopically receivable within casing 130 and aselector knob 134 that is interconnected with control member 126 in themanner shown in FIGS. 15 and 16. When the flow control member isproperly sealably positioned within outer casing 130, the inner surfaceof the outer casing wall cooperates with channels 128 provided in thecontrol member to form a plurality of generally spiral-shaped fluid flowpassageways of different overall lengths, width, depths and flowcapacities. Selector knob 134, which is rotatably mounted within housingportion 216, functions to rotate the assembly made up of outer casing130 and flow control member 126. In this way, a selected outlet 132 incasing 130 can be selectively aligned with an outlet flow passageway 118provided in forward housing portion 216 (FIG. 41).

Also forming a part of the fluid dispensing apparatus of the latest formof the invention is dispensing means for dispensing fluid to thepatient. This dispensing means is also identical to that previouslydescribed and comprises an administration set that is connected to thefirst portion 216 of housing 214 in the manner shown in FIG. 38 of thedrawings. The proximal end 116 a of administration line 116 of theadministration set is in communication with fluid passageway 118 in themanner best seen in FIG. 41.

It is also to be understood that, if desired, the reservoir of thebellows component can also be filled by alternate filling means of thecharacter previously described which comprises a syringe having a needleadapted to pierce the pierceable septum 84 which is mounted within thirdportion 220 of the apparatus housing. As the reservoir 58 fills withfluid from the fill-vials or from the filling syringe, any gases trappedwithin the reservoir will be vented to atmosphere via vent means “V”mounted in portion 216 of the housing.

Upon opening the fluid delivery path to the administration set, thestored energy means, or member 67, will tend to return to its startingconfiguration thereby controllably urging fluid flow outwardly ofreservoir 58 via the flow control means of the invention which functionsin the manner previously described. Indexing means of the characterpreviously described functions to index the position of the selectorknob. Similarly, as in the earlier described embodiments, disablingmeans of the character previously described can be used to disable theapparatus of this latest form of the invention.

Turning next to FIGS. 49 through 63, still another form of thedispensing apparatus of the present invention is there illustrated andgenerally designated by the numeral 242. This alternate form of theapparatus of the invention is also similar in many respects to thatshown in FIGS. 1 through 26 and like numerals are used in FIGS. 49through 63 to identify like components. The primary difference betweenthis latest form of the invention and that shown in FIGS. 1 through 26is that the vial-fill means for filling the device reservoir is of adifferent configuration from that used in each of the previouslydescribed embodiments of the invention. More particularly, as willpresently be described in greater detail, this alternate form ofvial-fill means comprises a first vial cartridge that is of identicalconstruction and operation to that described in connection with theembodiment of the invention shown in FIGS. 38 through 48. However, thevial-fill means also here includes a second vial cartridge that is of auniquely different construction from the previously described medicamentcontaining vials. More particularly, this second vial cartridge isspecially designed to enable the intermixing of an internally containedlypholized drug with a suitable diluent or mixing agent prior to thedelivery of the mixture of the fluid reservoir of the device.

As best seen in FIG. 49, the apparatus here comprises an outer housing242 having a first, second and third portions 244, 246 and 248respectively. Disposed within outer housing 242 is an inner, expandablehousing 56 which is identical in construction and operation to thatdescribed in connection with the embodiment of FIGS. 1 through 26.

Disposed within second portion 246 of outer housing 242 is the novelstored energy means of the invention for acting upon inner expandablehousing 56 in a manner to cause the fluid contained within fluidreservoir 58 thereof to controllably flow outwardly of the housing. Inthis latest form of the invention, this stored energy means is alsoidentical in construction and operation to that previously described andcomprises a constant force spring 67.

With regard to the fill means of this latest form of the invention,which is carried by the third portion 248 of the outer housing, asbefore, this important fill means functions to fill the reservoir 58with the fluid to be dispensed. This fill means here comprises thepreviously described septum-fill means, which is identical to thatpreviously described, and also includes the previously mentioned, firstand second cartridge-type vial-fill-vials generally designated in FIG.52 by the numerals 252 and 272 respectively. As to the septum-fillmeans, as illustrated in FIG. 52, third portion 248 includes a fluidpassageway 256 which is in communication with inlet 60 of fluidreservoir 58. Proximate its lower end 256 a, fluid passageway 256communicates with a cavity 258 formed within the third portion 248 ofthe housing. Disposed within cavity 258 is an elastomeric pierceableseptum 84 that comprises a part of the septum-fill means of this latestform of the invention. As before, septum 84 is held in position by aretainer 84 a and is pierceable by the needle of the syringe whichcontains the medicinal fluid to be dispensed and which can be used in aconventional manner to fill or partially fill reservoir 58 viapassageway 256.

Third portion 248 of the housing also includes a first chamber 260 fortelescopically receiving the previously mentioned, first cartridgefill-vial 252, which is identical in construction and operation to thepreviously described cartridge fill-vial 228, the construction of whichis shown in FIG. 41A. As illustrated in FIG. 52, a hollow needle 240 ismounted within third portion 248 of the device housing and is locatedproximate the inboard end of chamber 260. Hollow needle 240 is adaptedto pierce septum 236 when the first cartridge fill-vial is inserted intochamber 260 and pushed forwardly into the position shown in FIG. 52.

With respect to second reconstitution cartridge fill-vial 272, thisfill-vial, which is more clearly illustrated in FIGS. 53 and 54 of thedrawings, comprises a container of special design that uniquely containsa lyophilized drug 262 that is separated from a reconstituting fluid 264by a barrier stopper 266 (FIG. 53). Lyophilized drug 262 can, by way ofexample, comprise anti-infectives, cardiac drugs or various other typesof beneficial agents.

As illustrated in FIG. 52, portion 248 of the device housing includes apair of spaced-apart pusher members 268 and 270 which engage plungers237 and 271 respectively to push them forwardly of their respectivecontainer reservoirs.

Considering in more detail the novel bypass cartridge assembly 272, asbest seen in FIG. 53, this cartridge assembly includes a vial 272 thatis sealed at one end by elastomeric plunger 271 and at the other end bya pierceable septum 274 (FIGS. 52 and 53). Formed intermediate the endsof vial 254 is a raised outer wall portion 272 a which afterinstallation of the cartridge permits fluid 264 to bypass a barrierstopper 266 as the barrier stopper is urged inwardly of the container bypressure exerted thereon by the fluid 264, which is being pushed byplunger/stopper 271 resulting from force exerted on pusher elementmember 270. Fluid 264 exerts pressure on barrier member 266 as a resultof the inward movement of plunger 271 by the pusher member as the vialis fully mated with the apparatus housing.

A continued inward pressure exerted on plunger 271 will cause fluid 264to flow past barrier member 266 via the internal passageway defined wallportion 272 a so as to reconstitute the lyophilized drug 262. Acontinued pressure exerted on plunger 271 by the pusher member willcause the reconstituted drug formed by the fluid 264 which has beenintermixed with drug 262 to flow through a hollow cannula 240 past checkvalve 106, into a stub passageway 282 and then into a passageway 256 andfinally into the device reservoir 58.

As previously mentioned, plunger 237, which is disposed within vial 252,is moved by a support 268 of a vial cover 280 (FIG. 52) as the vialcover is mated with the apparatus housing and locked in position. Asplunger 237 is moved inwardly of vial reservoir 252, the fluid containedin the reservoir will be forced through the upper hollow needle 240,passed the upper umbrella check valve 106 mounted within third housingportion 248, into a stub passageway 282, into a passageway 256 andfinally into the device reservoir. As the fluid flows into the devicereservoir, it will compress the stored energy means, or constant forcespring 67 in the manner previously described.

Turning to FIGS. 55 and 56, an alternate form of drug intermixing vialis there shown. This fill-cartridge is similar in some respects tofill-cartridge 254 and includes a vial 285 that is sealed at one end bya plunger 286 and at the other end by a pierceable septum 274. Formedintermediate the ends of vial 285 is a plurality of internal fluid flowpassageways 292 which permit fluid 264 to bypass member or elastomericbarrier stopper 290 as the barrier stopper is urged inwardly of thecontainer by pressure exerted thereon by fluid 264. Fluid 264 exertspressure on barrier member 290 as a result of pusher member 270 of thehousing exerting inward pressure on plunger 286, which pressure is, inturn, caused by the inward movement of plunger 286 as vial housing 285is mated with the device housing portion 248.

A continued inward pressure exerted on plunger 286 will cause fluid 264to flow past barrier member 290 via flow passageways 292 so as toreconstitute lyophilized drug 262 (FIG. 55). Further pressure exerted onplunger 286 will cause the reconstituted drug formed by the fluid 264which has been intermixed with drug 262 to flow through hollow cannula240, past lower check valve 106, into a stub passageway 277, into apassageway 256 and finally into the device reservoir 58 (FIG. 52).

Forming an important aspect of the apparatus of this latest form of theinvention is a novel flow control means that is connected to firstportion 244 of the outer housing. This flow control means, which isidentical in construction and operation to that described in connectionwith the first embodiment of the invention, once again functions toprecisely control the rate outwardly of fluid flow from reservoir 58 andtoward the patient. As before, the flow control means comprises a flowcontrol member 126 that is telescopically receivable within casing 130and a selector knob 134 that is interconnected with control member 126in the manner shown in FIGS. 15 and 16. When the flow control member isproperly positioned within outer casing 130, the inner surface of theouter casing wall cooperates with channels 128 provided in the controlmember to form a plurality of generally spiral-shaped fluid flowpassageways of different overall lengths and flow capacities. Selectorknob 134, which is rotatably mounted within housing portion 244,functions to rotate the assembly made up of outer casing 130 and flowcontrol member 126. In this way, a selected outlet 132 in casing 130 canbe selectively aligned with an outlet flow passageway 118 provided inforward housing portion 244 (FIG. 52).

Also forming a part of the fluid dispensing apparatus of this latestform of the invention is dispensing means for dispensing fluid to thepatient. This dispensing means is also identical to that previouslydescribed and comprises an administration set 114 that is connected tothe first portion 244 of housing 242 in the manner shown in FIG. 49 ofthe drawings. The proximal end 116 a of administration line 116 of theadministration set is in communication with fluid passageway 118 in themanner best seen in FIG. 52.

It is also to be understood that, if desired, the reservoir of thebellows component can also be filled by alternate filling means of thecharacter previously described which comprises a syringe having a needleadapted to pierce the pierceable septum 84 which is mounted within thirdportion 248 of the apparatus housing. As the reservoir 58 fills withfluid either from the fill-vials or from the filling syringe, any gasestrapped within the reservoir will be vented to atmosphere via vent means“V” mounted in portion 244 of the housing.

Referring now to FIGS. 64 through 95, yet another embodiment of thedispensing apparatus of the present invention is there illustrated andgenerally designated by the numeral 302. This alternate form of theapparatus of the invention is similar in some respects to that shown inFIGS. 1 through 26 and like numerals are used in FIGS. 64 through 84 toidentify like components. The primary difference between this latestform of the invention and those previously discussed concerns theprovision of a differently configured device housing and a differentlyconfigured flow rate control means.

As best seen in FIG. 64, the apparatus here comprises an outer housing304 having first and second portions 306 and 308 respectively. Disposedwithin outer housing 304 is an inner, expandable housing 310, which isgenerally similar in construction and operation to expandable housing56, which housing was described in connection with the embodiment ofFIGS. 1 through 26.

Also disposed within second portion 308 of outer housing 304 is thenovel stored energy means of the invention for acting upon innerexpandable housing 310 in a manner to cause the fluid contained withinfluid reservoir 312 thereof to controllably flow outwardly of thehousing. In this latest form of the invention, this stored energy meansis identical in construction and operation to that previously describedand here comprises a constant force spring 67 of the characterpreviously described herein.

As in the earlier described embodiments of the invention, the presentinvention includes fill means, which are here carried by the firstportion 306 of the outer housing. As before, the fill means functions tofill the reservoir 312 with the fluid to be dispensed. As best seen inFIG. 67, first housing portion 306 includes a fluid passageway 313 thatis in communication with the inlet 312 a of fluid reservoir 312.Proximate its lower end 313 a, fluid passageway 313 communicates with acavity 315 formed within the first portion of the housing. Disposedwithin cavity 315 is a pierceable elastomeric septum 317 that comprisesa part of the fill means of this latest form of the invention. Septum317 is held in position by a retainer 317 a and is pierceable by theneedle of the syringe which contains the medicinal fluid to be dispensedand which can be used in a conventional manner to fill or partially fillreservoir 312 via passageway 313. As the reservoir fills, and gasestrapped within the reservoir will be vented via vents “V”.

Turning particularly to FIGS. 76 through 83, the novel flow controlmeans of the apparatus of this latest form of the invention is thereshown. This important flow control means functions to precisely controlthe rate outwardly of fluid flow from reservoir 312 and toward thepatient. In this latest form of the invention, the flow control meanscomprises a flow rate control assembly generally designated in thedrawings by the numeral 314. This flow rate control assembly isnon-rotatably mounted within housing portion 306 and includes anelongated spline 315 that functions to align the assembly within theouter housing. As best seen in FIGS. 76 and 77, this novel flow ratecontrol assembly here comprises an inlet manifold 316 having an inletport 318 (FIG. 76) that is in communication with the outlet 312 a of thefluid reservoir 312 (FIG. 69) and an outlet manifold 320 that isinterconnected with inlet manifold 316 by means of a plurality ofinterconnected flow rate control plates 322, 324, 326, 328, 330, 332,334, 336, 338 and 340 (see also FIG. 80). The rate control plates can beinterconnected by various well-known techniques including adhesive,sonic, thermal, laser and chemical bonding without disturbing theintegrity of the flow channels. As indicated in FIGS. 83 and 84, outletmanifold 320 has a plurality of circumferentially spaced outlet ports,each of which is in communication with an outlet port of a selected oneof the rate control plates. In a manner presently to be described, byusing the selector means of the apparatus these circumferentially spacedoutlet ports can be selectively brought into communication with outletpassageway 380 of the apparatus and with the administration line 341 ofthe administration set 343.

As best seen by referring to FIG. 80, each of the flow rate controlplates is provided with an elongated micro-channel of a particularconfiguration. These micro-flow channels can be formed in various waysknown to those skilled in the art. For example, U.S. Pat. No. 6,176,962issued to Soane, et al., describes methods for constructingmicro-channel structures for use in micro-fluidic manipulations.Similarly, International Publication WO 99/5694A1 describes suchmethods. When the rate control plates are assembled in the manner shownin FIGS. 80 and 83A, it is apparent that the micro-channel formed ineach of the rate control plates will cooperate with the adjacent planarsurface of the next adjacent rate control plate to form a fluid flowcontrol channel through which the fluid flowing into inlet 318 cancontrollably flow. As indicated in the drawings, one end of each of themicro-channels is in communication with the inlet port 318 of the inletmanifold 316 via a center port 319 and the other end of each of themicro-channel is in communication with a selected one of thecircumferentially spaced outlet ports provided in the outlet manifold320. More particularly, as can be seen by referring to FIGS. 80, 81 and84 of the drawings, outlet 322 a of rate control plate 322 is incommunication with outlet 341 of outlet manifold 320; outlet 324 a ofrate control plate 324 is in communication with outlet 342 of outletmanifold 320; outlet 326 a of control plate 326 is in communication withoutlet 343 of manifold 320; outlet 328 a of control plate 328 is incommunication with outlet 344 of outlet manifold 320 and outlet 330 a ofrate control 330 is in communication with outlet 345 of outlet manifold320, and outlet 332 a of rate control plate 332 is in communication withoutlet 346 of outlet manifold 320. In similar fashion, outlet 334 a ofrate control plate 334 is in communication with outlet 347 of outletmanifold 320; outlet 336 a of rate control plate 336 is in communicationwith outlet 348 of manifold 320 and outlet 338 a of control plate 338 isin communication with outlet 349 of outlet manifold 320 and outlet 340 aof rate control plate 340 is in communication with outlet 350 of outletmanifold 320.

With the construction of the flow control means shown in the drawings,fluid will flow from reservoir 312 into inlet port 318 of inlet manifold316, through a filter member 353 (FIGS. 82A and 83) and thence intomicro-channel 354 formed in plate 322. By controlling the length, widthand depth of the micro-channel 354, the rate of fluid flow flowingoutwardly of outlet 322 a can be precisely controlled. In a mannerpresently to be described, the fluid will then flow onwardly toward theadministration set via the flow regulation means of the invention. It isto be understood that micro-channel 354 can take various forms and canbe of varying length, width and depth to precisely control the rate offluid flow their through.

Fluid flowing through inlet port 318 will also flow into micro-channel356 formed in rate control plate 324. Once again, depending upon thelength, width and depth of micro-channel 356, the rate of fluid flowingoutwardly of outlet 324 a can be precisely controlled. In similarmanner, fluid flowing through inlet port 318 will fill micro-channel 358formed in rate control plate 326, will fill micro-channel 360 formed inplate 328, will fill micro-channel 362 formed in rate control plate 330,will fill rate control micro-channel 364 formed in rate control plate332, will fill rate control micro-channel 366 formed in rate controlplate 334, will fill rate control micro-channel 368 formed in ratecontrol plate 336, will fill flow control micro-channel 370 formed inrate control plate 338 and will fill rate control micro-channel 372formed in rate control plate 340. After flowing through the rate controlmicro-channels formed in the various indexedly aligned rate controlplates, the fluid will flow onwardly toward outlet manifold 320 and willfill each of the stub passageways 375 formed therein (FIGS. 84 and 85).The rate of flow of fluid flowing outwardly of each of the outlet portsof the various rate control plates will, of course depend upon theconfiguration of the individual rate control micro-channels formed inthe rate control plates.

As shown in FIG. 74, selector knob 378 is provided with a plurality ofcircumferentially spaced-apart indexing cavities 379 that closelyreceive an indexing finger 389, which forms a part of the indexing meansof the invention, which means comprises a front bezel 384 that isconnected to the apparatus housing (see FIGS. 64 and 75). Indexingfinger 389 is continuously urged into engagement with a selected one ofthe indexing cavities 379 by a coil spring 391 that also forms a part ofthe indexing means of the invention. Coil spring 391 can be compressedby an inward force exerted on an indexing shaft 393 that is movable froman extended position to an inward, finger release position whereinspring 391 is compressed and finger 389 is retracted from a selectedindexing cavity 379. With finger 389 in its retracted position, it isapparent that control knob 378 can be freely rotated to a positionwherein a gripping member 394 can be aligned with selected flow rateindicia 395 formed on the front bezel 384 of the apparatus housing.

When the selector knob is in the desired position and pressure isreleased on indexing shaft 393, spring 391 (FIG. 67) will urge finger389 of the indexing means of the invention into locking engagement withone of the indexing cavities 379 (FIG. 74) thereby placing a selectedone of flow control channels of a flow rate control plate incommunication with flow passageway 378 a (FIGS. 67A and 76) of the flowcontrol knob. As the fluid flows outwardly of the apparatus due to theurging of the stored energy means or spring member 67, the bellowsstructure 310 will be collapsed and at the same time member 69 willtravel inwardly of the housing. Member 69, which forms a part of thevolume indicator means of the invention, includes a radially outwardlyextending indicating finger 110 that is visible through a volumeindicator window 160 that is provided in a second portion 308 of theapparatus housing and also comprises a part of the volume indicatormeans of the invention. Indicia 161, which are provided on indicatorwindow 160 (FIG. 64), function to readily indicate to the caregiver theamount of fluid remaining within fluid reservoir 312 at any point intime.

Referring to FIGS. 64 and 73, disabling means, shown here as a disablingshaft 164 that is telescopically movable within a passageway formedwithin housing portion, functions in the manner previously described todisable the device.

Referring particularly to FIGS. 67, 76 and 77, a selector knob 378,which comprises a part of the selector means of the invention, issealably connected to outlet manifold 320 by means of O-Rings “O” and isrotatable with respect thereto. As previously mentioned, this novelselector means of the invention functions to control the flow of fluidfrom outlet manifold 320 toward the administration set 343. Moreparticularly, as illustrated in FIGS. 93, 93A and 93B, selector knob 378is provided with a circumferentially extending flow channel 378 a whichis selectively in communication with stub passageways 375 of outletmanifold 320 depending upon the position of the selector knob. Asillustrated in FIGS. 93A and 93B, the rearwardly extending generallycylindrical, reduced-diameter portion 378 c of the control knob, whichcircumscribes the outlet manifold 320, is provided with acircumferentially extending, elastomeric band 382 which prevents fluidleakage between then the outlet manifold and the flange 378 c. Outletmanifold 320 is also provided with a similarly configured,circumferentially extending, elastomeric band 384. As indicated in FIG.93A, elastomeric band 384 has an opening 384 a that is in alignment withfluid outlet passageway 380 formed in the first portion 306 of the outerhousing (see also FIG. 67). Elastomeric band 382 also has an opening 382a which is aligned with a radially extending flow passageway 378 bformed on portion 378 c of the control knob, which, in turn, is incommunication with circumferentially extending flow channel 378 a (FIG.93A). With this construction, when the control knob 378 is rotated to aposition such as that illustrated in FIG. 93A, wherein one of theoutlets of the outlet manifold 320 is in alignment with the opening 382a formed in the elastomeric band 382, fluid can flow from that outletand into circumferentially extending flow channel 378 a. From flowchannel 378 a, the fluid can flow into radially extending passageway 378b, through opening 384 a and into passageway 380. From passageway 380,the fluid can flow onwardly into the dispensing means or administrationset 343. The rate at which the fluid flows toward the administration setdepends, of course, upon which rate control plate outlet is incommunication with radial passageway 378 b formed in the control knob.By way of example, with the control knob 378 in the position shown inFIG. 93A, it is to be observed that the fluid flowing toward theadministration set is flowing from outlet 322 a of rate control plate322 and will flow at a rate determined by the configuration of ratecontrol micro-channel 354 (see FIGS. 80 and 80A).

Referring now to FIGS. 96 through 106, still another embodiment of thedispensing apparatus of the present invention is there illustrated andgenerally designated by the numeral 392. This alternate form of theapparatus of the invention is similar in some respects to that shown inFIGS. 64 through 95 and like numerals are used in FIGS. 96 through 106to identify like components. The primary difference between this latestform of the invention and that discussed in the embodiment of FIGS. 64through 95 concerns the provisions of a differently configured flow ratecontrol means. More particularly, the flow rate control means of thislatest form of the invention comprises a single fixed, non-variable flowrate control rather than a variable flow rate control as described inthe immediately preceding paragraphs.

As best seen in FIG. 96, this latest form of the apparatus of theinvention comprises an outer housing 394 having first and second portion396 and 398 respectively. Disposed within outer housing 394 is an inner,expandable housing 310, which is identical in construction and operationto the expandable housing, which was described in connection with theembodiment of FIGS. 64 through 95.

Disposed within second portion 398 of outer housing 394 is the novelstored energy means of the invention for acting upon inner expandablehousing 310 in a manner to cause the fluid contained within fluidreservoir 312 thereof to controllably flow outwardly of the housing(FIG. 101). In this latest form of the invention, this stored energymeans is identical in construction and operation to that previouslydescribed and here comprises a constant force spring 67.

As in the earlier described embodiment of the invention, the presentinvention includes fill means which are carried by the first portion 396of the outer housing. As before, the fill means functions to fill thereservoir 312 with the fluid to be dispensed. As best seen in FIG. 99,first portion 396 includes a fluid passageway 400 in communication withthe inlet 312 a of fluid reservoir 312. Proximate its lower end 400 a,fluid passageway 400 communicates with a cavity 402 formed within thefirst portion of the housing. Disposed within cavity 402 is a pierceableseptum 317 that comprises a part of the fill means of this latest formof the invention. Septum 317 is held in position by a retainer 317 a andis pierceable by the needle of the syringe which contains the medicinalfluid to be dispensed and which can be used in a conventional manner tofill or partially fill reservoir 312 via passageway 400. As the fluid tobe dispensed flows toward the fluid reservoir, any gases trapped withinthe reservoir will be vented to atmosphere through the vents “V”.

Turning particularly to FIGS. 99 through 101, the alternate form of theflow control means of the apparatus of this latest form of the inventionis there shown. As before, this alternate flow control means functionsto precisely control the rate outwardly to fluid flow from reservoir 312and toward the patient. In this latest form of the invention, the flowcontrol means comprises a flow rate control assembly generallydesignated in the drawings by the numeral 404. This novel flow ratecontrol assembly here comprises an inlet manifold 406 having an inletport 408 that is in communication with the outlet 312 a of the fluidreservoir 312 and a fixedly mounted, outlet manifold 410 that isinterconnected with inlet manifold 406 by means of a pair ofinterconnected plates 412 and 414. Plate 412 is identical inconstruction and operation to the previously describe flow rate controlplate 322 and is provided with a micro-channel 354 (see also FIGS. 80and 80A). Plate 414, on the other hand, is a generally cylindricallyshaped plate having planar front and rear surfaces. With thisconstruction, the rear surface of plate 414 cooperates with themicro-channel 354 of plate 412 to provide a closed flow control channelwhich controls the rate of fluid flow from the reservoir toward theadministration set of the apparatus of the invention. As indicated inthe drawings, outlet manifold 410 has an outlet passageway 416 that isin communication with the outlet port of rate control plate 412.

With the construction of the flow control means shown in the drawings,fluid will flow from reservoir 312 into inlet port 408 of the inletmanifold and then into micro-channel 354 formed in plate 412. Bycontrolling the length, width and depth of the micro-channel 354, therate of fluid flow flowing into outlet passageway 416 can be preciselycontrolled. As previously mentioned, the fluid will flow from passageway416 onwardly toward the administration set via the device outletpassageway 418 (FIG. 99).

As in the earlier described embodiments, that apparatus includes volumeindicator means and disabling means of the character previouslydescribed which can be used to determine the volume of fluid remainingin the device reservoir and, when desired to disable the apparatus.

Referring now to FIGS. 107 through 118, yet another embodiment of thedispensing apparatus of the present invention is there illustrated andgenerally designated by the numeral 422. This alternate form of theapparatus of the invention is similar in some respects to that shown inFIGS. 49 through 63 and like numerals are used in FIGS. 107 through 118to identify like components. The primary difference between this latestform of the invention and those previously discussed herein concerns theprovision of a fill means, such as that shown in the embodiment of theinvention illustrated in FIGS. 49 through 63, and the provision of aflow rate control means such as that shown in the embodiment of theinvention illustrated in FIGS. 64 through 95.

As best seen in FIG. 107, the apparatus here comprises an outer housing424 having first, second and third portions 426, 428 and 429respectively. Disposed within outer housing 424 is an inner, expandablehousing 430, which is generally similar in construction and operation toexpandable housing 310, which housing was described in connection withthe embodiment of FIGS. 64 through 95.

Also disposed within outer housing 424 is the novel stored energy meansof the invention for acting upon inner expandable housing 430 in amanner to cause the fluid contained within the fluid reservoir thereofto controllably flow outwardly of the housing. In this latest form ofthe invention, this stored energy means is identical in construction andoperation to that previously described and here comprises a constantforce spring 67 of the character previously described.

As in the earlier described embodiments of the invention, the presentinvention includes fill means, which are here carried by the thirdportion 426 of the outer housing. As before, the fill means functions tofill the reservoir defined by bellows member 430 with the fluid to bedispensed. As best seen in FIG. 108, third housing portion 429 includesa fluid passageway 433 that is in communication with the inlet orpassageway 435 of the fluid reservoir. Proximate its lower end 433 a,fluid passageway 433 communicates with a cavity 436 formed within thethird portion of the housing. Disposed within cavity 436 is a pierceableseptum 317 that comprises a part of the fill means of this latest formof the invention. Septum 317, which is identical in construction andoperation to that previously described, is held in position by aretainer 317 a and is pierceable by the needle of the syringe whichcontains the medicinal fluid to be dispensed and which can be used in aconventional manner to fill or partially fill the device reservoir viapassageway 433. As the reservoir fills, any gases trapped within thereservoir will be vented via vent “V”.

Turning particularly to FIG. 108, the novel flow control means of theapparatus of this latest form of the invention is there shown andincludes a flow rate control assembly generally designated by thenumeral 314. This important flow control means, which is identical inconstruction and operation to that discussed in connection with theembodiment of the invention shown in FIGS. 64 through 95, functions toprecisely control the rate outwardly of fluid flow from the devicereservoir and toward the patient. As before, flow rate control assembly314 is non-rotatably mounted within the outer housing and is of aconstruction illustrated in FIGS. 76 through 95. Reference should bemade to these Figure drawings and to the earlier discussion thereof tomore completely understand the construction and operation of this uniqueflow rate control assembly of this latest form of the invention.

As shown in FIG. 108, a selector knob 378, which is of an identicalconstruction to that previously described, is used to controllablyrotate the flow rate control assembly. Selector knob 378 as operablyassociated with the indexing means of the invention, which means is alsoidentical in construction and operation to that previously described.

As the fluid flows outwardly of the apparatus due to the urging of thestored energy means or spring member 67, the bellows structure 430 willbe collapsed and at the same time member 69 will travel inwardly of thehousing. Member 69, which forms a part of the volume indicator means ofthe invention, includes a radially outwardly extending indicating finger110 that is visible through a volume indicator window 160 that isprovided in a second portion 428 of the apparatus housing and alsocomprises a part of the volume indicator means of the invention. Indicia161, which are provided on indicator window 160 (FIG. 107), function toreadily indicate to the caregiver the amount of fluid remaining withinfluid reservoir of the device at any point in time.

Referring to FIG. 107, disabling means, shown here as a disabling shaft164 that is telescopically movable within a passageway formed within thehousing portion, functions in the manner previously described to disablethe device.

With regard to the fill means of this latest form of the invention,which is carried by the third portion 429 of the outer housing, asbefore, this important fill means functions to fill the device reservoirwith the fluid to be dispensed. This fill means here comprises thepreviously described septum-fill means and also includes the previouslymentioned fill-vials generally designated in FIG. 108 by the numerals252 and 254 respectively.

Turning to FIGS. 108 and 113 through 118, the fill-vials of the fillmeans of the dispensing apparatus of this latest form of the inventionare there illustrated. These fill-vials, which are of identicalconstruction and operation to those shown in FIG. 52 and earlierdescribed herein, comprise cartridge fill-vial 252 and a lyophilizeddrug fill-vial 254. As shown in FIG. 108, the third portion 429 of thehousing also includes a first chamber 440 for telescopically receivingcartridge fill-vial 252. As illustrated in FIG. 108, a hollow needle 442is mounted within third portion 429 of the device housing and is locatedproximate the inboard end of chamber 440. Hollow needle 442 is adaptedto pierce septum 236 when the cartridge fill-vial 252 is inserted intochamber 440 and pushed forwardly into the position shown in FIG. 108.

With respect to second cartridge fill-vial 254, this fill-vial, which ismore clearly illustrated in FIGS. 115 and 116 of the drawings comprisesa container of special design that uniquely contains a lyophilized drug262 that is separated from a reconstituting fluid 264 by a barrierstopper 266 (FIG. 115). Lyophilized drug 262 can, by way of example,comprise anti-infectives or various other types of beneficial agents.Cartridge fill-vial 254 is identical in construction and operation tothat shown in FIGS. 53 and 54 and previously described herein. As shownin FIG. 108, the third portion 429 of the housing also includes a secondchamber 448 for telescopically receiving cartridge fill-vial 254. Asillustrated in FIG. 108, a hollow needle 450 is mounted within thirdportion 429 of the device housing and is located proximate the inboardend of chamber 448. Hollow needle 450 is adapted to pierce septum 274when the cartridge fill-vial 254 is inserted into chamber 448 and pushedforwardly into the position shown in FIG. 108.

As illustrated in FIG. 108, the vial cover 443 of portion 429 of thedevice housing includes a pair of spaced-apart pusher members 445 and447 which engage plungers 237 and 270 respectively to push themforwardly of their respective container reservoirs (see also FIGS. 111and 112).

As the vial cover 443 is mated with the apparatus housing, the fluidcontained in the vial reservoirs will be forced through the upper andlower hollow needles 442 and 450, passed the upper umbrella check valves453 mounted within third housing portion 429, into a stub passageways455, into passageways 433 and 435 and finally into the device reservoir.As the fluid flows into the device reservoir, it will compress thestored energy means, or constant force spring 67, in the mannerpreviously described.

Turning to FIGS. 117 and 118, an alternate form of drug intermixing vialis there shown. This fill-cartridge is identical in construction andoperation to that previously described herein and illustrated in FIGS.55 and 56. This alternate form of drug intermixing vial can be used inplace of vial 254 during the reservoir filling step.

Having now described the invention in detail in accordance with therequirements of the patent statutes, those skilled in this art will haveno difficulty in making changes and modifications in the individualparts or their relative assembly in order to meet specific requirementsor conditions. Such changes and modifications may be made withoutdeparting from the scope and spirit of the invention, as set forth inthe following claims.

1. A dispensing apparatus for dispensing fluids to a patient comprising:(a) an outer housing having first and second portions, said secondportion having a cavity; (b) an expandable housing disposed within saidsecond portion of said outer housing, said expandable housing having afluid reservoir provided with an inlet for permitting fluid flow intosaid fluid reservoir and an outlet for permitting fluid flow from saidfluid reservoir, said expandable housing comprising a bellows structurehaving an accordion-like side wall movable from a substantiallycollapsed configuration to a substantially expanded configuration byfluid flowing into said fluid reservoir; (c) stored energy meansdisposed within said second portion of said outer housing for exerting aforce upon said inner expandable housing to cause the fluid containedwithin said fluid reservoir to controllably flow through said outlet,said stored energy means comprising an expandable, contractible constantforce spring carried within said outer housing; (d) fill means carriedby said first portion of said outer housing for filling said reservoirwith the fluid to be dispensed, said fill means comprising a pierceableseptum disposed within said cavity in said housing; (e) dispensing meanscarried by said outer housing for dispensing fluid to the patient; and(f) flow control means connected to said outer housing for controllingfluid flow between said reservoir and said dispensing means, said flowcontrol means comprising a flow control assembly, including an inletmanifold having an inlet port in communication with said fluid reservoirand an outlet port, a plurality of adjacent, fixedly connected plates,each having a planar surface and an inlet in communication with saidoutlet port of said inlet manifold, a plurality of flow rate controlplates each having a micro-channel formed therein; said planar surfacesof said flow rate control plates cooperating with said planar surfacesof said adjacent places having a micro-channel formed therein to form aplurality of fluid flow control channels, each said flow control channelhaving an outlet in communication with said dispensing means; and (g)selector means carried by said first portion of said outer housing forselectively bringing a selected one of said flow control channels intocommunication with said dispensing means.
 2. A dispensing apparatus fordispensing fluids to a patient comprising: (a) an outer housing havingfirst and second portions, said second portion having a cavity; (b) anexpandable housing disposed within said second portion of said outerhousing, said expandable housing having a fluid reservoir provided withan inlet for permitting fluid flow into said fluid reservoir and anoutlet for permitting fluid flow from said fluid reservoir, saidexpandable housing comprising a bellows structure having anaccordion-like side wall movable from a substantially collapsedconfiguration to a substantially expanded configuration by fluid flowinginto said fluid reservoir; (c) stored energy means disposed within saidouter housing for exerting a force upon said first expandable housing tocause the fluid contained within said fluid reservoir to controllablyflow through said outlet, said stored energy means comprising a constantforce extension spring carried within said outer housing, said constantforce extension spring comprising a coiled strip of pre-stressedmaterial that exerts a nearly constant restraining force to resistuncoiling, said constant force spring being retractable to cause fluidflow from said reservoir; (d) fill means carried by said first portionof said outer housing for filling said reservoir with the fluid to bedispensed, said fill means comprising a pierceable septum disposedwithin said cavity in said housing; (e) dispensing means carried by saidouter housing for dispensing fluid to the patient said dispensing meanscomprising an administration set; (f) flow control means connected tosaid outer housing for controlling fluid flow between said reservoir andsaid dispensing means, said flow control means comprising a flow controlassembly, including a plurality of adjacent non-rotatable, fixedlyconnected flow rate control plates each having a planar surface and acentral inlet in communication with said reservoir and selected ones ofsaid rate control plates having a micro-channel formed therein, saidflow control plates cooperating to form a plurality of flow channelseach having an outlet in communication with said dispensing means; and(g) selector means carried by said first portion of said outer housingfor selectively bringing a selected one of said flow control channelsinto communication with said dispensing means.